Class II — Cook Inc.
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. |
| Product | Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices |
| Quantity | 25 |
| Distribution | Distributed in the states of CA, FL, OK, OH, MI, TX, NJ, and NY. |
| Initiated | 2016-01-20 |
| Classified | 2016-02-24 |
| Terminated | 2016-11-21 |
| Recall number | Z-0865-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Cook Inc. (Z-0865-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/73163/
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